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AVANIR Pharmaceuticals announces filing of Complete Response to FDA Approvable Letter for Zenvia

AVANIR Pharmaceuticals, Inc. (NASDAQ: AVNR) today announced the submission of its Complete Response to the October 2006 Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for Zenvia™ (dextromethorphan/quinidine) for the treatment of pseudobulbar affect (PBA). AVANIR expects the FDA to classify the response as a Class 2 resubmission, which would result in an expected review period of 180 days and potential approval of Zenvia in the fourth calendar quarter of 2010.

3 May 2010

Taking vitamin D supplements during pregnancy safe for mother, baby: Study

Taking vitamin D supplements during pregnancy is not only safe for mother and baby, but also can prevent preterm labor/births and infections, according to results of a randomized controlled study to be presented at the Pediatric Academic Societies annual meeting in Vancouver, British Columbia, Canada.

3 May 2010

Watson Pharmaceuticals sued in connection with filing ANDA for generic equivalent of Trilipix

Watson Pharmaceuticals, Inc. today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with the filing of Watson's Abbreviated New Drug Application for choline fenofibrate delayed-release capsules in the 45 mg and 135 mg strengths.

3 May 2010

Nearly 85% of adolescents at risk of overdosing on acetaminophen: Study

The majority of teens say they have never heard of acetaminophen - or what the appropriate dosing of it is even with access to the label instructions - despite having taken the medication recently, according to a new University of Rochester Medical Center Study assessing teens' health literacy. More than 60 percent of the teens in the study had never before heard of acetaminophen despite 21 percent of them having taken it within the previous month.

3 May 2010

FDA oks 'vaccine' to treat prostate cancer

Provenge, developed by Dendreon Corporation, is the first approved "treatment that uses a so-called cancer vaccine, a drug that trains the body's own immune system to fight the disease," The New York Times reports.

3 May 2010

Probiotic supplementation helps ELBW infants gain weight: Study

Extremely low birthweight infants who received feedings supplemented with probiotics had better weight gain than infants who were not given the supplements, according to a randomized, controlled, double-blind study to be presented Saturday, May 1 at the Pediatric Academic Societies annual meeting in Vancouver, British Columbia, Canada.

3 May 2010

Eating more olive oil could help prevent ulcerative colitis: UEA study

Eating more olive oil could help prevent ulcerative colitis, according to a new study co-ordinated by medical researchers at the University of East Anglia.

3 May 2010

Preclinical safety data reports Natural S-equol has little effect on 2 reproductive hormones

Natural S-equol, a novel soy germ-based compound, is very likely the primary ingredient for reducing hot flushes in the dietary supplement SE5-OH, which is under development for reduction of menopause symptoms, according to pre-clinical efficacy data from studies using an animal model presented at the Experimental Biology 2010 annual meeting.

3 May 2010

Vita Breath may contain hazardous levels of lead, warns FDA

The U.S. Food and Drug Administration is advising consumers not to purchase nor consume Vita Breath, a dietary supplement manufactured by American Herbal Lab Inc. of Rosemead, Calif., and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead.

3 May 2010

SGB procedure holds potential promise for PTSD treatment

Walter Reed Army Medical Center in Bethesda, MD, has published case reports detailing the successful treatment of combat-related post-traumatic stress disorder with a stellate ganglion block.

3 May 2010

FDA issues complete response letter for Bristol-Myers Squibb's belatacept

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration has issued a complete response letter regarding the Biologics License Application for belatacept in kidney transplantation.

3 May 2010

DHA supplements during lactation increases DHA status in preterm infants

Docosahexaenoic acid (DHA), an omega-3 fatty acid, is essential for the growth and development of infants' brains. Very premature infants may be deficient in DHA because they miss out on the third trimester in utero when the fatty acid accumulates in tissues. In addition, their gastrointestinal system is immature, and health problems often increase the risk of malnutrition.

3 May 2010

VIMOVO delayed-release tablets receive FDA approval

AstraZeneca and POZEN Inc. today announced the U.S. Food and Drug Administration has approved VIMOVO (naproxen and esomeprazole magnesium) delayed-release tablets for the relief of signs and symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis, and to decrease the risk of developing gastric ulcers in patients at risk of developing NSAID-associated gastric ulcers.

3 May 2010

Vitamin E effective in treating NASH: Study

Vitamin E has been shown effective in treating nonalcoholic steatohepatitis, an obesity-associated chronic liver disease that can lead to cirrhosis, liver cancer, and death. NASH also is related to or a part of type 2 diabetes, lipid disorders and cardiovascular disease.

3 May 2010

Codeine containing preparations lose their OTC status

It will get more difficult to procure Codeine based pain killers, cough syrups etc. from the local pharmacists from now on. There have been new restrictions over codeine based drugs like Nurofen Plus, Panadeine and Mersyndol which were initially sold over the counter but lost this OTC status with effect from May 1st 2010. The National Drugs and Poisons Schedule Committee formulated the changes during meetings in June and October last year.

2 May 2010

Seasonal flu vaccine ups the risk of getting H1N1 flu

Initial reports linking seasonal flu vaccine and getting swine flu or H1N1 flu emerged September 2009 in Canada. In spring 2009 many people who acquired pandemic H1N1 flu had been initially vaccinated with seasonal flu vaccine. This triggered four additional studies in Canada to explore the link further. The studies included 2,700 patients with or without H1N1. The first of the studies showed a surprising 68 percent rise of risk of development of H1N1 flu in those vaccinated with seasonal flu shot. The other 3 studies showed increase of risk of H1N1 flu by 1.4 to 1.5 times with the original flu shot.

2 May 2010

Inergetics signs three-year exclusive distributor agreement with Windmill Health Products

Inergetics, Inc., a leader in targeted product development for the Clinical Nutrition and Sports Supplement Markets, today announced that the Company has agreed in principle with Windmill Health Products to a three year exclusive distributor relationship to sell and market its Surgex sports supplement across multiple classes of trade worldwide.

30 Apr 2010

Update on BioSante cancer vaccine portfolio to be presented at BIO International Convention

BioSante Pharmaceuticals, Inc. will present a BioSante cancer vaccine portfolio update at the BIO International Convention, which will take place May 3-6 in Chicago, Illinois.

30 Apr 2010

NovaBay to present data on Aganocide compounds at ARVO annual meeting

NovaBay Pharmaceuticals, Inc. announced today that the latest public data on its Aganocide® compounds, a new class of broad-spectrum antimicrobials, will be presented during three poster sessions at the Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale, Florida.

30 Apr 2010

NeurogesX announces $40 million royalty financing agreement with Cowen Royalty

NeurogesX, Inc., a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that that it has entered into a $40 million royalty financing agreement with Cowen Healthcare Royalty Partners, L.P. ("Cowen Royalty").

30 Apr 2010